US7063088B1 - Intraoral endotracheal tube holder and method for intubation - Google Patents

Abstract

A tube holder assembly and method for securing an endotracheal tube to a biteline of a patient's mouth. The tube holder assembly features a tube body. A bite support assembly, coupled to the tube body, receives a tensile force and supplies a compressive force to the mouth of the patient. The bite support assembly includes a pair of substantially parallel bite walls extending outwardly from the exterior surface of the tube body. The bite walls define a bite rest therebetween for receiving a biteline of the patient's mouth and thus securing the biteline between a pair of bite walls as the bite rest applies a compressive force to the biteline.

Description

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention generally relates to an intraoral tube holder assembly for supporting an endotracheal tube. More particularly, but not by way of limitation, the present invention relates to a system and method for securing an endotracheal tube to a biteline of a patient's mouth wherein the system incorporates the features of both a tube holder and bite block in a single tube holder assembly.

2. Description of the Related Art

Intubation is a well known medical procedure referring to the placement of a tube in to a body orifice. Endotracheal intubation, a very common intubation procedure, directs a tube from either the mouth or the nose through the larynx to the trachea for fluid engagement therein. Most often, tracheal intubation is applied in emergency medicine especially during cardiopulmonary resuscitation, CPR; for intensive care patients under respiratory support; for protecting the airways of comatose or intoxicated patients; and for general anesthesia applications.

Often, tube holders are incorporated with endotracheal intubation procedures for supporting and maintaining the position of the endotracheal tube during a medical procedure. Many typical tube holders include a mounting plate for applying pressure to the face, such as onto the lips of the mouth, onto the cheekbone area or a combination thereof to secure the tube holder in place. Oftentimes adhesives are included with or act in conjunction with the mounting plate to enhance overall stability of current tube holders.

Unfortunately, today's tube holders create many difficulties for medical practitioners and patients alike. Many typical tube holders feature a complex array of mounting plate configurations for application to the face of the patient whereby operational setup is time consuming and laborious.

In particular, set up often needlessly involves several physicians and nurses who take turns maintaining the position of the endotracheal tube while the complicated array of mounting plates and adhesives of many typical tube holder are properly situated on to the patient by the team of medical practitioners. The application of adhesives in combination with a complex mounting plate arrangement allows very little opportunity for readjustment of the tube holder during a medical procedure as relocating mounting plates becomes cumbersome and adhesives lose their initial bonding strength.

Furthermore, the complex arrangements of many typical tube holders today often obstruct clear entry into the mouth, which is critically important for suction, inspection, maintaining the cleanliness of the endotracheal tube as well as maintaining the health of the patient's mouth during long term care. Dirt and bodily secretions such as saliva, sweat, oils from the skin, and blood delivered by the patient onto the mounting plates and associated adhesives diminish the overall operative effectiveness of a tube holder as well as the overall sterile integrity thereof. It should be added that prolonged application of pressure by the tube holders against the skin of the face could lead to trauma or ulceration from the mounting plates. Unfortunately there is no known compact device or method for operatively holding an endotracheal tube during intubation that is simple and easy to use for both the medical practitioner and patient alike.

Therefore, a need exists for a system and method for securing an endotracheal tube to a patient's mouth, simply, quickly, and without unnecessary complications to the patient's face. Many other problems and disadvantages of the prior art will become apparent to one skilled in the art after comparing such prior art with the present invention as herein described.

SUMMARY OF THE INVENTION

Aspects of the invention are found in a tube holder assembly and method for securing an endotracheal tube to a biteline of a patient's mouth. The tube holder assembly is compact, requires no adhesive support, and facilitates easy adjustment and readjustment of the endotracheal tube by a single medical practitioner.

In one aspect, the tube holder assembly features a tube body having an exterior surface, an interior surface, and a pass-through slit along the length of the tube body. Operatively, an endotracheal tube is inserted through the pass-through slit to the interior surface and is placed in direct contact about the circumference of the tube body defined by the interior surface, hereinafter referred to as “circumferential contact”.

A bite tensioner mount is coupled to the tube body and receives a tensile force from a bite tensioner assembly. The bite tensioner assembly features two opposing ends having a tensioner lock at one end and anchor webbing at another end. Operatively, the tensioner lock is secured to the bite tensioner mount of the tube body whereas anchor webbing is fixed to the patient so that a tensile force is exerted along the bite tensioner assembly from the tensioner lock to the anchor webbing. Anchor webbing is advantageous for securing the bite tensioner assembly to the patient's body, especially in instances where hair, oil, skin, and dirt provide slippage at particular locations as compared with the overall surface area contact provided by the anchor webbing.

A bite support assembly, coupled to the tube body, receives a tensile force from the bite tensioner mount and supplies a compressive force to the mouth of the patient. The bite support assembly includes a pair of substantially parallel bite walls extending outwardly from the exterior surface of the tube body. The bite walls define a bite rest therebetween for receiving the biteline of a patient's mouth and thus securing the biteline between the pair of bite walls as the bite rest applies a compressive force to the biteline. Accordingly, the surface of biteline contact defined by a first bite wall, the bite rest, and an adjacent, second bite wall forms a trough-like configuration, such as either a U or V shape, for ensuring that the biteline is securedly clamped therein. In one aspect, the separation between the first and second bite wall with respect to the bite rest forms a geometric angle in a range between 10° and 90°. It should be added that the term “substantially parallel” refers to the condition of being in a range from nearly parallel to exactly parallel. ‘substantially parallel’ refers to the condition providing one bitewall extending outwardly from the exterior surface of the tube body having a distal portion that does not intersect with a distal portion of another outwardly extending bitewall and whereby these distal portions are relatively aligned in a range from nearly parallel to exactly parallel to one another.

In one aspect, the tube holder assembly may include a peripheral fastening assembly coupled to the exterior surface of the tube body. In operation, the peripheral fastening assembly receives at least one peripheral tube thereby coupling the at least one peripheral tube to the exterior surface of the tube body. In effect, with the peripheral fastening assembly, additional tubes may be attached to the tube holder assembly during intubation such as for example a nasogastric tube, an orogastric tube, an esophogeal thermometer, and Dobhoff feeding tube.

In one aspect, a method for intubating a patient includes inserting an endotracheal tube within a tube holder assembly via a pass-through slit extending along the length of the tube body. An endotracheal tube is directed through to a desired position with respect to a patient's trachea. In one aspect, a tube holder assembly is secured to a bite line of a patient's mouth via a bite support assembly coupled to the tube body. Accordingly, the bite support assembly is compressed against the biteline of a patient. The endotracheal tube is locked in place via a slit tensioning assembly to ensure no undesired movement of the endotracheal tube with respect to the tube holder assembly. In one aspect, the tube holder assembly is anchored to the patient's head via a bite tensioner mount coupled to the tube holder assembly. Other aspects, advantages, and novel features of the present invention will become apparent from the detailed description of the present invention when considered in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustrated by way of example and not by limitation in the accompanying figures, in which like references indicate similar elements, and in which:

FIG. 1 is an isometric view illustrating a tube holder assembly for securing an endotracheal tube to a patient's biteline according to the present invention, the tube holder assembly includes a bite support assembly coupled to a tube body for applying a compressive force while clamped around the biteline;

FIG. 2 is an orthographic view from the side illustrating one exemplary embodiment of a tube holder assembly; the tube holder assembly includes a pass-through slit for inserting an endotracheal tube therein and a slit tensioning assembly for narrowing the pass-through slit after insertion;

FIG. 3 is an isometric view from the side illustrating one exemplary embodiment of a tube holder assembly featuring a bite support assembly;

FIG. 4 is an isometric view from the side illustrating one exemplary embodiment of a tube holder assembly featuring a bite support assembly;

FIG. 5 is an isometric view from the top illustrating one exemplary embodiment of a tube holder assembly, the tube holder assembly features an array of grip enhancers positioned about the interior surface for compression against the endotracheal tube and at least one peripheral fastening assembly for securing a respective peripheral tube such as a nasogastric tube to the exterior surface of the tube holder assembly during intubation;

FIG. 6 is an isometric view from the bottom illustrating one exemplary embodiment of a tube holder assembly, the tube holder assembly features bite grooves disposed along the exterior surface for enhanced frictional contact with the patient's mouth;

FIG. 7 is a partially cut-away, perspective view of an intubation system for attachment to a biteline of a patient's mouth, the intubation system includes an endotracheal tube and a tube holder assembly, the tube holder assembly including a bite support assembly and a bite tensioner assembly both coupled to a tube body, the bite tensioner assembly applies a tensile force to the tube body for enabling the bite support assembly to compress against the patient's biteline, and

FIG. 7ais a detailed view of the intubation system ofFIG. 7;

FIG. 8 is a partially cut-away, perspective view illustrating one exemplary embodiment of an intubation system for attachment to a biteline of a patient's mouth, the intubation system including a bite support assembly having a buccal side bite wall extending from the biteline and in contact with the attached gingival, and a lingual side bite wall extending from the biteline an din contact with the hard palate, and

FIG. 8ais a detailed view of the intubation system ofFIG. 8;

FIG. 9 is an exploded, isometric view illustrating one exemplary embodiment of a tube holder assembly, the tube holder assembly including a tube body and a bite support assembly pivotally coupled to the tube body via a ball joint coupling and socket chamber;

FIG. 10 is an orthographic view from one end illustrating one exemplary embodiment of a bite wall coupled to a holding tube;

FIG. 11 is an orthographic view from one end illustrating one exemplary embodiment of a bite wall coupled to a holding tube;

FIG. 12 is an orthographic view from one end illustrating one exemplary embodiment of a bite wall coupled to a holding tube;

FIG. 13 is an orthographic view from one end illustrating one exemplary embodiment of a bite wall coupled to a holding tube; and

FIG. 14 is an isometric view from one end illustrating one exemplary embodiment of a bite support assembly coupled to a holding tube.

Skilled artisans appreciate that elements in the Figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the Figures may be exaggerated relative to the other elements to help improve understanding of the embodiments of the present invention.

DETAILED DESCRIPTION

For a more complete understanding of the present invention, preferred embodiments of the present invention are illustrated in the Figures. Like numerals being used to refer to like and corresponding parts of the various accompanying drawings. It is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms.

FIG. 1 illustrates one aspect, among others, of atube holder assembly10 for securing an endotracheal tube to a biteline of a patient's mouth. Generally, during a medical procedure, a tube holder assembly maintains a desired position of an endotracheal tube as it is firmly secured onto the biteline of a patient. Illustratively,FIGS. 7 and 8 show an intubation system for attachment to a biteline whereby a bite tensioner assembly applies a tensile force to a tube holder assembly for fixating the tube holder assembly against the biteline of a patient. In this disclosure and appended claims the term “biteline” refers to a row of teeth and including the peridontum of a patient's mouth in the absence of at least one tooth, whereby the term “patient” refers to either a human or an animal. Moreover, the endotracheal tube may comprise any endotracheal tube of a type well known in the industry, such as an endotracheal tube with or without an inflatable cuff as well as a dual bore endotracheal tube.

Specifically referring toFIG. 1, thetube holder assembly10 includes atube body20. Thetube body20 features anexterior surface21, aninterior surface25, and a pass-throughslit23 formed betweenexterior surface21 and theinterior surface25.

In one exemplary embodiment, thetube body20 is composed of a flexible, semirigid material such as a polymer. Thetube body20 must be sufficiently rigid so as to withstand compressive forces from the upper and lower jaws of a patient as thetube holder assembly10 is operatively secured to the biteline.

Moreover, thetube body20 is sufficiently flexible so as to hingedly receive and secure an endotracheal tube against theinterior surface25.FIG. 1 shows ahinge portion22 defined by thetube body20. Thehinge portion22 is located on thetube body20 on the opposite side with respect to the pass throughslit23. Operatively, as the pass-through slit is either enlarged or narrowed, thehinge portion22 exhibits flexture having characteristic hinge-like properties.

In one exemplary embodiment, thetube body20 may optionally feature at least oneretainment lip27. Operatively, as it wedges against an endotracheal tube, a retainment lip prevents rotational slippage of an endotracheal tube with respect to an interior surface. Moreover, as an endotracheal tube is inserted within a tube body, an outward budge characteristic of the retainment lip assists in manually prying-open a pass-through slit.

Theretainment lip27 shown inFIG. 1 is located adjacent to the pass-throughslit23. As it extends along the length of the pass-throughslit23, theretainment lip27 bulges outwardly from a plane that generally defines theinterior surface25.

In one exemplary embodiment, thetube body20 may integrate sensors such as electrical or electrothermal sensors of a type well known in the industry for collecting biomedical data from a patient's mouth, such as for temperature reading or pulse. For example, at least one sensor may be coupled to thetube body20 for engagement with a patient's mouth. Accordingly, in one exemplary embodiment, a power supply may be coupled to thetube body20 to provide power to the sensor.

As shown inFIG. 1, an array ofgrip enhancers29 are optionally provided about theinterior surface25 of thetube holder assembly10. In operation, the array ofgrip enhancers29 provide added surface area to theinterior surface25 for securing the endotracheal tube to theinterior surface25. Specifically, each grip enhancer extends outwardly from theinterior surface25 thereby providing added surface area for frictional contact against the endotracheal tube. Grip enhancers may assume a variety of shapes that are well known in the industry for providing frictional enhancement. For example, grip enhancers may assume a combination of different shapes such as pyramidal shapes as shown inFIG. 1, grooved shapes, hatched configurations, spherical shapes as shown inFIG. 5, rifled configurations as shown inFIG. 6, and gritted configurations as shown inFIG. 9.

Generally, thetube body20 is compact in size to permit medical practitioners to access the entire mouth as need. In operation, illustratively for humans, a tube body may radially extend from 0.1 to 10.0 millimeters (mm.) outwardly from the endotracheal tube. Furthermore, the length of a tube body may range from 1 to 8 centimeters, (cm.).

Thetube body20 is dimensioned to securedly receive an endotracheal tube, especially endotracheal tubes of varying sizes. In one exemplary embodiment, the size of the interior diameter of thetube body20 may be configured to exactly accommodate the exterior diameter size of a corresponding endotracheal tube. Specifically, an exact accommodation may require that the entire outer diameter of the endotracheal tube circumferentially and continuously contacts the tube body's20interior surface25 such that the pass-throughslit23 is entirely drawn together without any gap therebetween.

Illustratively, endotracheal tubes for humans fall within the inner diameter size range between 2.0 mm. and 10.0 mm. at 0.5 mm increments. Most human adults require an endotracheal tube inner diameter size between 6.0 mm. and 9.0 mm. To accommodate each particular outer diameter size of endotracheal tube, tube bodies may be provided at corresponding incremental inside diameter sizes. For example, an individual requiring a 7.5 mm. outer diameter endotracheal tube will receive a corresponding tube holder assembly from an array of available tube holder sizes having a tube body with an inside diameter slightly larger than 7.5 mm. and whereby the interior surface of the tube body circumferentially and continuously contacts the entire outer diameter of the endotracheal tube such that the pass through slit is drawn together and closed without a gap therebetween.

Although shown inFIG. 1 as cylindrical in shape, it should be added that a tube body in cross-section may encompass a variety of shapes including cylindrical, square, hexagonal, and octagonal configurations. Cross-sectional shapes are either varied or constant throughout the entire length of a tube body. Moreover, in one exemplary embodiment, a tube body may be bent at least in part along its length so as to ultimately affect the positioning of the endotracheal tube with respect to the patient.

In operation, an endotracheal tube is inserted within thetube holder assembly10. Specifically, the endotracheal tube is inserted from theexterior surface21 across the pass-through slit23 to theinterior surface25, and is placed in circumferential contact with theinterior surface25. Alternatively, in one exemplary embodiment, thetube holder assembly10 may be formed from one contiguous piece that does not feature a pass-through slit. Accordingly, one end of an endotracheal tube may be fed through one end of thetube holder assembly10 without insertion across a pass-through slit.

Thetube holder assembly10 may further include aslit tensioning assembly30. In operation, theslit tensioning assembly30 applies a narrowing force to the pass-throughslit23 so that theinterior surface25 is compressively secured against the endotracheal tube.

As shown inFIG. 1, theslit tensioning assembly30 includes at least oneslit tensioning pull33 and a correspondingslit tensioning anchor31 for operative engagement with theslit tensioning pull33. Eachslit tensioning pull33 and correspondingslit tensioning anchor31 is secured to theexterior surface21 at opposing locations relative to the pass-throughslit23.

Operatively, theslit tensioning pull33 is drawn to close a gap defined by the pass-throughslit23. To ensure that the pass-throughslit23 remains closed, theslit tensioning anchor31 locks the slit tensioning pull33 in place. The slit tensioning pull33 may be configured to include adjustable locking positions with respect to theslit tensioning anchor31.

Theslit tensioning pull33 andanchor device31 for the embodiment ofFIG. 1 are of a type well known in the industry. It should be added that theslit tensioning assembly30 ofFIG. 1 may include a plurality of slit tensioning pulls and corresponding slit tensioning anchors to ensure that the endotracheal tube is locked in position with respect to theinterior surface25. Illustratively, theslit tensioning pull33 may comprise a continuous cam array for ratcheting and, thus, locking to theslit tensioning anchor31 as shown inFIG. 1. Alternatively, theslit tensioning pull33 may comprise a cord having an array of beaded stoppers placed at a predetermined position whereby a desired stopper is secured to a correspondingslit tensioning anchor31 comprising a locking rest.

In one exemplary embodiment, thetube holder assembly10 may optionally provide at least oneperipheral fastening assembly35 coupled to theexterior surface21 of thetube body20. Generally, theperipheral fastening assembly35 is configured for receiving at least one peripheral tube thereby coupling the at least one peripheral tube to theexterior surface21. A peripheral tube may comprise any suitable tube of a type well known in the industry for use in conjunction with a tracheal intubation procedure. Illustratively, a peripheral tube may comprise a nasogastric tube, an orogastric tube, and esophageal thermometer. During intubation, as thetube holder assembly10 secures an endotracheal tube to the biteline of a patient's mouth, other tubes such as a nasogastric tube may be secured to theexterior surface21 of thetube holder assembly10. Those of ordinary skill in the art will readily recognize any suitable means for securing a peripheral tube to theexterior surface21 of a type well known in the industry such as hooks, loops, and a pull and corresponding anchor device similar to that ofslit tensioning assembly30.

Thetube holder assembly10 ofFIG. 1 further includes abite support assembly40 coupled to thetube body20. It should be said that in one exemplary embodiment thetube body20 and thebite support assembly40 are formed as one integral piece. Generally, thebite support assembly40 receives a tensile force and supplies a compressive force to the mouth of a patient. In effect, thebite support assembly40 clasps around the biteline and supplies a compressive force thereto so as to anchor thetube holder assembly10 to the biteline.

Specifically, thebite support assembly40 includes a pair of substantiallyparallel bite walls44. In one exemplary embodiment, thebite support assembly40 includes a pair of exactlyparallel bite walls44. Thebite walls44 extend outwardly from theexterior surface21 of thetube body20. As shown inFIG. 1, thebite walls44 define a bite rest45 in the space between thebite walls44.

The bite rest45 in operation receives the biteline of the patient's mouth thereby securing the biteline between eachbite wall44 as the bite rest45 applies a compressive force to the biteline. Accordingly, the surface of biteline contact defined by a first bite wall, the bite rest, and an adjacent, second bite wall forms a trough-like configuration, such as either a U or V shape, for ensuring that the biteline is securedly clamped therein. In one aspect, the separation between the first and second bite wall with respect to the bite rest forms a geometric angle in a range between 10° and 90°. In one exemplary embodiment, thebite support assembly40 may comprise a tray that form fits onto the biteline.

As shown inFIG. 1, thetube holder assembly10 further comprises a bite tensioner mount47 coupled to thetube body20. The bite tensioner mount47 operatively receives a tensile force from a bite tensioner assembly coupled to the bite tensioner mount47 as discussed in detail below.

FIG. 2 illustrates one exemplary embodiment of atube holder assembly50. Thetube holder50 includes atube body51 having afront portion52 and an opposingmouth portion53. Thetube holder assembly50 further includes abite support assembly60 coupled to thetube body50. Referring to the embodiment ofFIG. 2, the length of thefront portion52 exposed outside of the mouth is relatively longer than the length of themouth portion53 operatively situated within the mouth. Accordingly, enhanced length of thefront portion52 exposed outside of the mouth permits medical practitioners to manually clamp along this area during standard intubation procedures such as securing the intubation tube within the tube holder.

For the embodiment ofFIG. 2, thebite support assembly60 is coupled at an offset position relative to the center of thetube body51. As shown, thebite support assembly60 is positioned toward themouth portion53 and away from thefront portion52. Accordingly, in operation, thefront portion52 provides sufficient room for manual contact of thetube holder assembly50 during standard intubation procedures.

Illustratively, the tube holder assembly includes aslit tensioning assembly70 for applying a narrowing force to a pass-throughslit75. Accordingly, a medical practitioner may manually clamp against thefront portion52 while manipulating theslit tensioning assembly70 to lock theassembly70 in place so that, ultimately, thetube body51 is compressively secured against an endotracheal tube. Specifically, theslit tensioning assembly70 features a slit tensioning pull73 having astop71 that is drawn to rest against a correspondingslit tensioning anchor75 as thefront portion52 receives a manual clamping force thereon.

Thetube holder50 also provides aperipheral fastening assembly79 and is positioned on thefront portion52 for accommodating ease of manual access thereto. For example, for the embodiment ofFIG. 2, theperipheral fastening assembly79 comprises a hook for receiving and securing a peripheral tube such as a nasogastric tube to thefront portion52 of thetube holder assembly50.

Referring toFIG. 2, thebite support assembly60 includes a pair ofbite walls63 extending away from one another and outwardly from thetube body51. Thebite walls63 define abite rest66 therebetween. Thetube holder assembly50 further includes abite tensioner mount59 coupled to thetube body50 for receiving a tensile force and permitting thebite rest66 to apply a compressive force to a biteline to thereby secure thetube holder assembly50 to the biteline of a patient's mouth.

FIG. 3 is a side view illustrating one exemplary embodiment of atube holder assembly90 for securing an endotracheal tube to a biteline. Thetube holder assembly90 includes atube body91. Thetube holder assembly90 further includes aslit tensioning assembly97, abite tensioner mount99, and abite support assembly100 each coupled to thetube body91.

Specifically, thebite support assembly100 includes a pair ofbite walls101 rendered in a symmetrically opposing configuration. Eachbite wall101 ofFIG. 3 is of the same length. Eachbite wall101 is composed of a semirigid material so as to ultimately clasp around the biteline while maintaining complete structural integrity of thetube holder assembly90. Optionally, in one exemplary embodiment, eachbite wall101 may be composed of a partially deformable, rigid material such as metal so as to ultimately form fit around the biteline as it is clasped thereon without compromising structural integrity of thetube holder assembly90. As shown inFIG. 3, a cushioning element103 is secured on to thebite support assembly100 specifically from the distal end of onebite wall101 across abite rest107, as defined between eachbite wall101, and to the distal end of theother bite wall101. In effect, the cushioning element103 protects the patient's biteline from trauma and provides comfort during extended periods of use. For example, the cushioning element may be composed at least in part of foam including memory foam, gel, and batting and other soft materials.

FIG. 4 is a side view illustrating one exemplary embodiment oftube holder assembly110. Thetube holder assembly110 includes atube body111. Thetube body111 features a pass-throughslit114 formed along the length of thetube body111 and a hinge portion opposedly located from the pass-throughslit114. Operatively, thehinge portion113 facilitates the opening and closing of the pass-throughslit114 to accommodate the insertion of an endotracheal tube.

Thetube holder assembly110 further includes abite support assembly120 is coupled to anexterior surface115 of thetube body111. Moreover, as shown in the embodiment ofFIG. 4, the bite support assembly situated at a predetermined bite deflection angle, α, that is measured from the normal axis to the radial plane defining theexterior surface115. Those of ordinary skill in the art will readily recognize that the bite deflection angle α as any angle suitable for enabling thebite support assembly120 to deliver the maximum amount of compressive force to the biteline. Illustratively, in one exemplary embodiment, the bite deflection angle α may be any acute angle relative to the normal axis of theexterior surface115.

Referring toFIG. 4, thebite support assembly120 includes afirst bite wing121 and asecond bite wing123 coupled to thefirst bite wing121. Thefirst bite wing121 and thesecond bite wing123 join together so as to form abite rest122 for receiving the biteline of a patient's mouth and, in operation, securing the pair ofbite wings121,123 to the biteline as thebite rest122 applies compressive force to the biteline. In one exemplary embodiment, thesecond bite wing123 is characterized as having a relatively longer length as compared to thefirst bite wing121. Operatively, thefirst bite wing121 is situated on the biteline facing the lips of the patient's mouth whereas thesecond bite wing123 is positioned entirely within the mouth from the biteline and extending outwardly along the length of a patient's hard palate.

Optionally, thebite support assembly120 further includes acushioning element126 disposed along thebite support assembly120 from the distal end of thefirst bite wing121 across thebite rest122 to the distal end of thesecond bite wall123. Thecushioning element126 is provided for ergonomic support as thebite support assembly120 is clasped to the biteline.

FIG. 5 is a top view illustrating one exemplary embodiment of atube holder assembly130. Thetube holder assembly130 includes atube body133 for securedly receiving an endotracheal tube holder therein. Thetube holder assembly130 ofFIG. 5 includes abite tensioner mount149 coupled to thetube body133 for receiving a tensile force. In one exemplary embodiment, thebite tensioner mount149 comprises a flanged element. Operatively, abite support assembly145 receives the tensile force from thebite tensioner mount149 and supplies a compressive force to the mouth of the patient. Furthermore,FIG. 5 showsgrip enhancers137 for frictional engagement with an endotracheal tube placed circumferentially against theinterior surface135.

Thetube holder assembly130 further includes aslit tensioning assembly146 for applying a narrowing force to theinterior surface135 to the interior surface so that theinterior surface135 is compressively secured against the endotracheal tube. Optionally, thetube holder assembly130 may include at least oneperipheral fastening assembly140 for securing peripheral tubes to thetube body133.

FIG. 6 is a bottom view illustrating one exemplary embodiment of atube holder assembly160. Thetube holder assembly160 includes atube body166 having aninterior surface167 and anexterior surface170.Grip enhancers169 are disposed on theinterior surface167 of thetube body166 so as to ultimately secure the endotracheal tube against theinterior surface167. Specifically, in one exemplary embodiment, the grip enhancers are rendered in a rifled configuration whereby at least one spiraled grip enhancer is positioned about theinterior surface167.

The embodiment ofFIG. 6 further includesbite groves163 disposed along theexterior surface170 defined by thetube body166. Operatively, thebite groves163 frictionally engage with teeth and tissues associated with the lower jaw such as the lower lip, peridontum, cheek, and tongue to ultimately prevent slippage by the tube holder assembly.

It should be added that abite tensioner mount177 is provided by thetube holder assembly166. Thebite tensioner mount177 features a ring-like configuration.

FIG. 7 is a schematic diagram illustrating anintubation system201 for attachment to abiteline207 of a patient'smouth203. Theintubation system201 includes anendotracheal tube208. During standard intubation procedures, theendotracheal tube208 is directed through thetracheal tube205. Theendotracheal tube208 may be an endotracheal tube of a type well known in the industry. Moreover, an endotracheal tube may be selected from an array of predetermined diameter sizes.

Theintubation system201 further includes atube holder assembly200 coupled to theendotracheal tube208. Thetube holder assembly200 includes atube body210. Thetube body210 includes an exterior surface, an interior surface, and a pass-through slit extending along the length of thetube body210. Operatively, theendotracheal tube208 is inserted from the exterior surface, across the pass-through silt to the interior surface for operative contact with the interior surface as shown inFIG. 7.

Thetube holder assembly200 further includes abite tensioner assembly222 and abite tensioner mount220 coupled to thetube body210. In operation, thebite tensioner assembly222 applies a tensile force to thebite tensioner mount220. As shown inFIG. 7, thebite tensioner assembly222 features two opposing ends having atensioner lock219 andanchor webbing226 at another end. Thetensioner lock219 is secured to thebite tensioner mount220. Theanchor webbing226 is fixed to the patient's body such that the tensile force is exerted along thebite tensioner assembly222 from thetensioner lock219 at thebite tensioner mount220 to theanchor webbing226. Optionally, an array of tensioner locks may be applied on thebite tensioner assembly222 for variable adjustment according to the body size of the patient as well as the degree of tensile force desired for engagement with abite tensioner mount220.

Illustratively, as shown inFIG. 7, theanchor webbing226 is secured about the frontal and parietal regions of the patient's skull. Securing theanchor webbing226 can be achieved by a single medical practitioner. Moreover, in one exemplary embodiment, thebite tensioner assembly222 is composed of a resilient material such that theanchor webbing226 is stretched over the skull that consequently exerts a tensile force at thetensioner lock219. In one exemplary embodiment, the tensioner assembly includes a belt buckle assembly (not shown) having a belt buckle for drawing a tension on thebite tensioner assembly222 from thetensioner lock220 to anchorwebbing226.

Thetube holder assembly200 further includes abite support assembly215 coupled to thetube body210. Operatively, thebite support assembly215 receives the tensile force from thebite tensioner mount220 and supplies a compressive force to themouth203 of a patient. Specifically, thebite support assembly215 includes a pair of substantiallyparallel bite walls217–18 extending outwardly from the exterior surface of thetube body210.

Generally, the bite walls define a bite rest for receiving thebiteline207 thereby securing thebiteline207 between the pair ofbite walls217–18 as the bite rest applies a compressive force to thebiteline207. Securing both thebite support assembly215 and theanchor webbing226 can be achieved by a single medical practitioner.

As specifically shown inFIG. 7a, thebite support assembly215 includes afrontal bite wall217 operatively positioned between the patient's lip and biteline. Thebite support assembly215 further includes arearward bite wall218 coupled to thefrontal bite wall217. Therearward bite wall218 is positioned within themouth203 and rests against thebiteline207 and extends across thehard palate204 of thepatient207.

Specifically referring toFIG. 7, the tube holder assembly further includes a bite tensioner mount coupled to thetube body210. In operation, the bite tensioner assembly applies a tensile force to the bite tensioner mount coupled to the tube body.

Generally,FIGS. 7 and 8 illustrate at least one method for intubating a patient. For example, referring toFIG. 7, an endotracheal tube is inserted within a tube holder assembly. The endotracheal tube is passed through an interior surface of the tube body as it is ultimately directed through the patient'strachea205. The tube holder assembly is secured onto abiteline207 of the patient's mouth.

In one exemplary method, the tube holder assembly further includes a bite support assembly coupled to the tube body. The bite support assembly receives a tensile force from a bite tensioner mount. Accordingly, the bite support assembly, supplies a compressive force to the mouth of the patient. Optionally, in one exemplary embodiment, the bite support assembly includes a ball joint coupling for ultimately pivoting the tube holder assembly with respect to the biteline.

As the endotracheal tube is placed in a desired position with respect to thetrachea205, the endotracheal tube is locked in place via the tube holder assembly. In particular, the tube holder assembly further includes a slit tensioning assembly. Operatively, the slit tensioning assembly narrows the pass through slit so that the interior surface is compressively secured against the endotracheal tube.

The bite tensioner assembly anchors the tube holder assembly to the patient's head to ensure a fixed, stable attachment of the bite support assembly to the biteline as a patient is generally lying at rest during a tracheal intubation procedure. Accordingly, the bite tensioner assembly is positioned on the patient's head in an area that is easily accessible and typically free of the patient's skin, muscle or joint movement.

As illustrated inFIGS. 7 and 8, the anchor webbing may assume a variety of configurations for ultimately securing the tube holder assembly to the biteline. For example, inFIG. 7, the bite tensioner assembly is secured to the parietal and/or frontal regions of the patient's skull. Illustratively, the parietal region is a non-obstructive location for most procedures involving tracheal intubation and provides little biomechanical movement as a tensile force is drawn across the bite tensioner assembly and applied to the tube holder assembly.

FIG. 8 is a perspective view illustrating one exemplary embodiment of anintubation system252. Theintubation system252 includes atube holder assembly250 having abite support assembly269 coupled to atube body270. Thebite support assembly269 includes a pair of bite walls, specifically a buccalside bite wall273 and a lingualside bite wall274. “Buccal” refers to the area of the mouth near the lips and cheeks that is anterior to the teeth and gums whereas “lingual” refers to the area of the mouth posterior to the teeth and gums within the mouth cavity including the hard palate and tongue.

As shown inFIG. 8, the lingualside bite wall274 extends from abite line285 outwardly against the hard palate. As shown inFIG. 8a, the buccalside bite wall273 extends from the biteline and contacts against the attached gingiva. It should be added that the biteline ofFIG. 8 includes teeth and peridontum whereby the bite support assembly clamps against all or a portion of the teeth and optionally the gingiva. Accordingly, the buccalside bite wall274 extends across the teeth and gum line to ultimately enhance overall support of thetube holders250. Theanchor webbing292 is shown inFIG. 8 to extend against both the frontal and parietal regions of the skull for increased fixation to the patient.

FIG. 9 is an exploded view illustrating one exemplary embodiment of atube holder assembly300 for pivotal attachment to a biteline. In general, thetube holder assembly300 is similar to the tube holder assemblies referenced inFIGS. 1 through 8. Thetube holder assembly300 includes atube body340 having an interior surface. Thetube body340 ofFIG. 9 features aspacer region341 formed above theinterior surface340. Thespacer region341 defines asocket chamber344 therein.

Thetube holder assembly300 further includes abite support assembly330 pivotally coupled to thetube body340. Thebite support assembly330 includes a pair of substantiallyparallel bite walls331. As shown inFIG. 9, the pair ofbite walls331 are mounted to and joined together by a bitewall coupling mount335. Optionally, acushioning element337 may be coupled to thebite walls331.

A balljoint coupling334 is secured to and extends from thebite coupling mount335. The balljoint coupling334 is set at least in part within thesocket chamber334. In effect, the balljoint coupling334 slides about thesocket chamber344, thereby pivotally coupling thebite support assembly330 to thetube body340. Those of ordinary skill in the art will readily recognize that tolerance between the balljoint coupling334 and thesocket chamber344 may provide a range between loose and tight pivotal adjustment.

In one exemplary embodiment, as shown inFIG. 9, thetube body340 includes abite tensioner mount349 coupled to thetube body340 for receiving a tensile force from a bite tensioner assembly (not shown). Operatively, the pivotal coupling between thebite support assembly330 and thetube body340 enables the bite tensioner mount to position thetube body340 from side-to-side or up and down as the bite tensioner assembly is situated on to the patient.

Alternatively, a bite tensioner mount may be coupled to thebite support assembly330. In particular, the bite tensioner mount may be secured to thebite wall coupling335. In one exemplary embodiment, the bite tensioner mount may extend outwardly from the bitewall coupling mount335 and from thebite walls331 so as not to interfere with operation of thebite walls331. The bite tensioner mount receives a tensile force from the bite tensioner assembly to thus secure thebite support assembly330 to a biteline. As thesupport assembly330 is secured to the biteline, the balljoint coupling334 andsocket chamber344 permit thetube body340 and ultimately the endotracheal tube to be pivotally adjusted during intubation independently from the fixated bite support assembly.

Generally,FIGS. 10 through 14 illustrate some configurations, among others, of at least one bite wall with respect to a holding tube. In effect, the bite walls shown inFIGS. 10–14 are configured to conform to the biomechanical features associated with the biteline to effectively clamp thereon for up to long periods within the mouth. Those of ordinary skill in the art will readily recognize other suitable configurations for each bite wall so as to effectively affectively engage with a patient's biteline.

FIG. 10 shows at least onebite wall352 coupled to a holdingtube351. Thebite wall352 includes an outwardly extending tab portion. The outwardly extending tab portion is provided for increased contact surface area with the region associated with the biteline.

FIG. 11 shows at least onebite wall354 coupled to a holdingtube353. Thebite wall354 features a plurality of elongated members for contact with area associated with the biteline. For example, thebite wall354 may be used to clamp against teeth on either side of a gap created by a missing tooth or teeth.

FIG. 12 illustrates at least onebite wall356 coupled to a holdingtube355. Thebite wall356 features a plurality of outwardly extending tab portions. Each tab provides increased contact surface area with the region associated with the biteline.

FIG. 13 illustrates atube body360 coupled to bitewall361. Thebite wall361 is configured to sufficiently conform to the basic contours associated with the hard palate.

FIG. 14 illustrates a holdingtube363 coupled to abite support assembly366. Thebite support assembly366 features at least onebite wall370. The at least onebite wall370 is curved so as to directly conform to the contours associated with the biteline.

Although the present invention has been described in detail, it should be understood that various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the invention as defined by the appended claims.

Claims (18)

1. A tube holder assembly for securing an endotracheal tube to a biteline of a patient's mouth via a tensile force, the tube holder assembly comprising:

a tube body,

the tube body including an exterior surface and an interior surface, the endotracheal tube received by the tube body and is placed in circumferential contact against the interior surface;

a bite tensioner mount coupled to the tube body and receiving the tensile force; and

a bite support assembly coupled to the tube body,

the bite support assembly receiving the tensile force from the bite tensioner mount and supplying a compressive force to the mouth of the patient,

the bite support assembly including a pair of substantially parallel bite walls extending outwardly from the exterior surface of the tube body,

the bite walls defining a bite rest therebetween, the bite rest receiving the biteline of the patient's mouth thereby securing the biteline between the pair of bite walls as the bite rest applies the compressive force to the biteline.

2. The tube holder assembly according toclaim 1 wherein the tube body further includes a pass-through slit extending along the length of the tube body.

3. The tube holder assembly according toclaim 1 wherein the endotracheal tube is inserted from the exterior surface across the pass-through slit to the interior surface and is placed in circumferential contact against the interior surface.

4. The tube holder assembly according toclaim 1 further comprising a bite tensioner assembly for applying the tensile force to the bite tensioner mount.

5. The tube holder assembly according toclaim 1 wherein the bite tensioner assembly includes two opposing ends and wherein one end includes a tensioner lock and another end includes anchor webbing.

6. The tube holder assembly according toclaim 1 wherein the tensioner lock is secured to the tensioner mount of the tube body and the anchor webbing is fixed to the patient, the tensile force is exerted along the bite tensioner assembly from the tensioner lock to the anchor webbing.

7. The tube holder assembly according toclaim 1 wherein the bite tensioner assembly is composed of a resilient material.

8. The tube holder assembly according toclaim 1 further comprising a slit tensioning assembly, the slit tensioning assembly applies a narrowing force to the pass-through slit, the narrowing force compressively secures the interior surface against the endotracheal tube.

9. The tube holder assembly according toclaim 1 wherein the slit tensioning assembly includes a slit tensioning pull and a slit tensioning anchor, each secured to the exterior surface at opposing locations relative to the pass-through slit.

10. The tube holder assembly according toclaim 1 further comprising a peripheral fastening assembly coupled to the exterior surface, the peripheral fastening assembly configured for receiving at least one peripheral tube thereby coupling the at least one peripheral tube to the exterior surface of the tube body.

11. The tube holder assembly according toclaim 1 wherein the tube body is composed of a flexible, semirigid material.

12. The tube holder assembly according toclaim 1 wherein the tube body and bite support assembly form one integral piece.

13. The tube holder assembly according toclaim 1 wherein the bite support assembly is pivotally coupled to the tube body.

14. A tube holder assembly for securing an endotracheal tube to a biteline of a patient's mouth, the tube holder assembly comprising:

a tube body,

the tube body including an exterior surface, an interior surface, and a pass-through slit extending along the length of the tube body, the endotracheal tube is applied from the exterior surface across the pass-through slit to the interior surface and is placed in circumferential contact against the interior surface;

a bite tensioner mount coupled to the tube body;

a bite tensioner assembly for applying a tensile force to the bite tensioner mount,

the bite tensioner assembly including a tensioner lock secured to the bite tensioner mount and anchor webbing fixed to the patient so that the tensile force is exerted along the bite tensioner assembly from the tensioner lock to the anchor webbing; and

a bite support assembly coupled to the tube body,

the bite support assembly receiving the tensile force from the bite tensioner mount and supplying a compressive force to the mouth of the patient,

the bite support assembly including a pair of substantially parallel bite walls extending outwardly from the exterior surface of the tube body,

the bite walls defining a bite rest therebetween, the bite rest receiving the biteline of the patient's mouth thereby securing the biteline between the pair of bite walls as the bite rest applies the compressive force to the biteline.

15. A method for intubating a patient comprising the steps of:

inserting an endotracheal tube within a tube holder assembly,

the tube holder assembly including a tube body having an exterior surface, an interior surface, and a pass-through slit extending along the length of the tube body;

passing the endotracheal tube through the patient's trachea, the endotracheal tube passing through the interior surface of the tube body;

securing the tube holder assembly to a biteline of the patient's mouth,

the tube holder assembly further including a bite support assembly coupled to the tube body,

the bite support assembly receiving the tensile force from a bite tensioner mount and supplying a compressive force to the mouth of the patient,

the bite support assembly including a pair of substantially parallel bite walls extending outwardly from the exterior surface of the tube body,

the bite walls defining a bite rest therebetween, the bite rest receiving the biteline of the patient's mouth thereby securing the biteline between the pair of bite walls as the bite rest applies the compressive force to the biteline;

locking the endotracheal tube in place via the tube holder assembly,

the tube holder assembly further including a slit tensioning assembly for operatively narrowing the pass-through slit so that the interior surface is compressively secured against the endotracheal tube; and

anchoring the tube holder assembly to the patient's head,

the tube holder assembly further including a bite tensioner mount coupled to the tube body and a bite tensioner assembly for applying a tensile force to the bite tensioner mount, the bite tensioner assembly including a tensioner lock secured to the bite tensioner mount and anchor webbing fixed to the patient's head so that the tensile force is applied along the bite tensioner assembly from the tensioner lock to the anchor webbing.

16. The method according toclaim 15 wherein the step of inserting the endotracheal tube within a tube holder assembly further comprises the step of directing the endotracheal tube from the exterior surface across the pass-through slit to the interior surface for placement in circumferential contact against the interior surface.

17. The method according toclaim 15 wherein the step of securing the tube holder assembly to the biteline of the patient's mouth further comprises the step of pivoting the tube holder assembly with respect to the biteline via the bite support assembly, the bite support assembly including a ball-joint coupling.

18. The method according toclaim 15 further comprising the step of coupling a peripheral tube to the tube holder assembly, the tube holder assembly including a peripheral fastening assembly coupled to the exterior surface, the peripheral fastening assembly configured for receiving at least one peripheral tube thereby coupling the at least one peripheral tube to the exterior surface of the tube body.

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